Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2017

March 1, 2019 updated by: Dr. Wang Man-Ping, The University of Hong Kong

Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2017: a Single-blind Cluster Randomized Controlled Trial on a Combined "Cocktail" Intervention of Brief Advice, Instant Messaging and Active Referral (AIR) to Increase Abstinence

The present study will examine (1) the effectiveness of regular messages and semi-personalized instant messaging with AWARD brief advice and active referral to smoking cessation (SC) services and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Although smoking prevalence is decreasing in Hong Kong, there are still 641,300 daily smokers (10.5%) and half will be killed by smoking which accounts for over 7,000 deaths per year. Smoking also accounts for a large amount of medical cost, long-term care and productivity loss of US$688 million (0.6% Hong Kong GDP). Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. On the other hand, reaching and helping the many smokers who have no intention to quit is a challenge, because they are unlikely to seek professional help from smoking cessation services.

The Quit and Win programme provides an opportunity to reach and encourage a large group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that smokers participating in the contest will have higher motivation to quit with incentives and better social support. Studies have found that such quitting contests or incentive programs appeared to reach a large number of smokers and demonstrated a significantly higher quit rate for the quit and win group than for the control group.

Smoking cessation services in Hong Kong are under-used with most of the adult daily smokers (79.6%) who had never used smoking cessation services. Among these smokers, only 2.4% were willing to use the services. Our previous RCT in previous QTW Contest 2015 evaluated the effects of low-intensity active referral (LAR) vs. very brief general SC advice (VBA) on quitting. LAR included onsite AWARD counselling and collection of smokers' personal contact information for SC services providers to connect with the smokers. Findings at 3-month follow-up of this RCT suggested the LAR intervention resulted in significantly higher self-reported quit rate than VBA in the control group (18.7% vs. 14.0%. P<0.001). Our RCT in previous QTW Contest 2016 evaluated the effects of a higher intensity and personalized active referral (HAR) vs. low intensity text messaging (SMS) vs. very brief SC advice (VBA; control group) on encouraging smoking cessation (SC) service use and increasing the quit rate. Findings at 6-month follow-up of the QTW 2016 RCT showed that the intervention group with HAR had a significantly higher self-reported quit rate than VBA (the control group) (17.0% vs. 11.2%, P = 0.02). Text messaging group also had significantly higher self-reported quit rate than the control group (17.1 % vs. 11.2%, P = 0.02).

However, these SMS-based RCTs could not provide real-time responses from the counsellors, which might weaken the smokers' intention to quit and lower the intensity of social support. In the present proposal, we hope to enrich the SMS-based intervention by using social media such as WhatsApp or WeChat etc., which can provide an interactive platform and develop a semi-personalized interactive IM system that can tailor for the smokers according to their characteristics, needs and demand.

Therefore, the present study will examine (1) the effectiveness of regular messages and semi-personalized instant messaging with AWARD brief advice and active referral to smoking cessation (SC) services and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1311

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Hong Kong Council on Smoking and Health (COSH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hong Kong residents aged 18 or above
  • Smoke at least 1 cigarette per day in the past 3 months
  • Able to communicate in Cantonese (including reading Chinese)
  • Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO Smokerlyzer.
  • Intent to quit / reduce smoking
  • Using a cell phone with instant messaging tool (e.g. WhatsApp, WeChat)
  • Able to use instant messaging tool (e.g. WhatsApp, WeChat) for communication

Exclusion Criteria:

  • Smokers who have communication barrier (either physically or cognitively)
  • Have participation in other smoking cessation programmes or services

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Instant Messaging IM + regular messages +AWARD advice + warning leaflet + referral card
Behavioral: AWARD advice
Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
Other Names:
  • Ask, Warn, Advise, Refer, Do-it-again
Behavioral: Referral card
The 3-folded "Smoking Cessation Services" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans
Other Names:
  • Smoking Cessation Service Card
Behavioral: COSH booklet
A general smoking cessation self-help booklet
Other Names:
  • COSH self-help smoking cessation booklet
Behavioral: Instant Messaging IM
Smokers can communicate with counsellors in real-time through instant messaging (social media). Our counsellors will trigger the conversation and invite the smokers to response after initial contact. Counsellors will keep contact with the smokers to offer help, positive encouragement, reflections and reminders about SC according to smokers' personal needs and to encourage them to seek SC services. Details of successfully booked SC appointment (e.g. SC services address, contact information, date, appointment number etc.) will be delivered to the smokers using IM. All smokers will receive a reminder-to-attend IM messages 1-3 days before the appointment date.
Other Names:
  • Instant messaging interaction
Behavioral: Regular messages
Regular messages, including: harm of smoking, benefit of smoking cessation, importance of adherence to smoking cessation appointment and encouragement on abstinence will be sent to smokers after initial contact via social media.
Other Names:
  • Regular messages focusing active referral and encouragement
Behavioral: Warning Leaflet
The leaflet will include the information about the health risks of smoking.
Experimental: Group B
COSH booklet + general brief advices +Placebo Messages
Behavioral: Brief advice
Very brief, minimal and general smoking cessation advice
Other Names:
  • Brief smoking cessation advice
Behavioral: COSH booklet
A general smoking cessation self-help booklet
Other Names:
  • COSH self-help smoking cessation booklet
Behavioral: Placebo Messages
Placebo messages will be sent via smart phones (e.g. social media) to remind subjects to take follow-up calls before each follow-up time points.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biochemical validated quit rate at 6-month follow-up
Time Frame: 6-month follow-up
Biochemically validated quit rates at 6-month in the two groups
6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Smoking reduction rate change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
Rate of smoking reduction by at least half of baseline amount in the two groups
3-month follow-up
Smoking reduction rate change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
Rate of smoking reduction by at least half of baseline amount in the two groups
6-month follow-up
Biochemical validated quit rate
Time Frame: 3-month follow-up
Biochemically validated quit rates at 3-month in the two groups
3-month follow-up
Smoking quit rate change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups
3-month follow-up
Smoking quit rate change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 6-month between the two groups
6-month follow-up
Smoking quit attempt change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
Number of quit attempts at 3-month in the two groups
3-month follow-up
Smoking quit attempt change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
Number of quit attempts at 6-month in the two groups
6-month follow-up
Quit rate for all subjects change from baseline at 3- and 6-month follow-up
Time Frame: 3 and 6 months follow-up
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2017
3 and 6 months follow-up
Reduction rate for all subjects change from baseline at 3- and 6-month follow-up
Time Frame: 3 and 6 months follow-up
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2017
3 and 6 months follow-up
Use of smoking cessation service
Time Frame: 3 and 6 months follow-up
Use of smoking cessation at 3 and 6 month follow-up in the two groups
3 and 6 months follow-up
Use of smoking cessation service for all subjects
Time Frame: 3 and 6 months follow-up
Use of smoking cessation service for all subjects participating in Quit to Win contest 2017
3 and 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hong Kong Council on Smoking and Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Man Ping Kelvin Wang, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QTW 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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